Maa: Singapore
Kieli: englanti
Lähde: HSA (Health Sciences Authority)
Esomeprazole Magnesium Trihydrate 22.3mg EQV Esomeprazole
ASTRAZENECA SINGAPORE PTE LTD
A02BC05
20 mg
TABLET, FILM COATED
Esomeprazole Magnesium Trihydrate 22.3mg EQV Esomeprazole 20 mg
ORAL
Prescription Only
AstraZeneca AB
ACTIVE
2001-04-27
1 10/AD/SG/GI.000-059-920.12.0 NEXIUM ESOMEPRAZOLE TABLETS 20 MG AND 40 MG COMPOSITION Each tablet contains: 20 mg or 40 mg esomeprazole (as magnesium trihydrate). For excipients see "List of excipients". PHARMACEUTICAL FORM Gastro-resistant tablets 20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A EH on the other side. 40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and A EI on the other side. INDICATIONS Nexium tablets are indicated for: GASTROESOPHAGEAL REFLUX DISEASE (GERD) - Treatment of erosive reflux esophagitis. - Long-term management of patients with healed esophagitis to prevent relapse. - Symptomatic treatment of gastroesophageal reflux disease (GERD). IN COMBINATION WITH AN APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMEN FOR THE ERADICATION OF _HELICOBACTER PYLORI_ AND - Healing of _Helicobacter pylori_ associated duodenal ulcer and 2 - Prevention of relapse of peptic ulcers in patients with _Helicobacter pylori_ associated ulcers. PATIENTS REQUIRING CONTINUED NSAID THERAPY - Healing of gastric ulcers associated with NSAID therapy. - Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric and/or duodenal ulcers. Controlled studies do not extend beyond 6 months. PATIENTS REQUIRING CONTINUED LOW DOSE ASPIRIN (75-325 MG) THERAPY - Prevention of gastric and/or duodenal ulcers associated with low dose aspirin therapy, in patients at risk. PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING TREATMENT WITH NEXIUM IV SOLUTION BY INTRAVENOUS INFUSION. TREATMENT OF ZOLLINGER ELLISON SYNDROME POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. For patients who have difficulty in swallowing, the tablets can also be Lue koko asiakirja
1 NEXIUM MUPS ® (ESOMEPRAZOLE) 1. NAME OF THE MEDICINAL PRODUCT Nexium MUPS ® Esomeprazole Tablets 20 mg and 40 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each Multiple-Unit Pellet System (MUPS) tablet contains: 20 mg or 40 mg esomeprazole (as magnesium trihydrate). For excipients see "List of excipients". 3. PHARMACEUTICAL FORM GASTRO-RESISTANT TABLETS 20 mg: A light pink, oblong, biconvex, film-coated tablet engraved 20 mg on one side and A EH on the other side. 40 mg: A pink, oblong, biconvex, film-coated tablet engraved 40 mg on one side and A EI on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nexium MUPS tablets are indicated for: GASTROESOPHAGEAL REFLUX DISEASE (GERD) • Treatment of erosive reflux esophagitis. • Long-term management of patients with healed esophagitis to prevent relapse. • Symptomatic treatment of gastroesophageal reflux disease (GERD). IN COMBINATION WITH AN APPROPRIATE ANTIBACTERIAL THERAPEUTIC REGIMEN FOR THE ERADICATION OF HELICOBACTER PYLORI AND • Healing of _Helicobacter pylori_ associated duodenal ulcer and • Prevention of relapse of peptic ulcers in patients with _Helicobacter pylori_ associated ulcers. PATIENTS REQUIRING CONTINUED NSAID THERAPY • Healing of gastric ulcers associated with NSAID therapy. 2 • Prevention of gastric and duodenal ulcers associated with NSAID therapy in patients at risk. Patients are considered to be at risk due to their age ( 60) and/or documented history of gastric and/or duodenal ulcers. Controlled studies do not extend beyond 6 months. PATIENTS REQUIRING CONTINUED LOW DOSE ASPIRIN (75-325 MG) THERAPY • Prevention of gastric and/or duodenal ulcers associated with low dose aspirin therapy, in patients at risk. PREVENTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING TREATMENT WITH NEXIUM IV SOLUTION BY INTRAVENOUS INFUSION TREATMENT OF ZOLLINGER ELLISON SYNDROME 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The tablets should be swallowed whole with liquid. The tablets should not be chewed or crushed. Lue koko asiakirja